(57 days)
The MSFX Mikron Cervical Anterior Plate System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:
-Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- Trauma (including fractures)
-Tumors
-Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
-Pseudarthrosis
-Failed previous fusion
-Decompression of the spinal cord following total or partial cervical vertebrectomy
-Spondvlolisthesis
-Spinal stenosis.
The MSFX Cervical Anterior Plate System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation.
The MSFX Mikron cervical anterior plate configurations ranging in lengths from 17 mm to 25 mm for the one-level plates, 27 mm to 40 mm for the two-level plates, 45 mm to 65 mm for the three-level plates, and 70 mm to 90 mm for the four -level plates All of the plate levels incorporate blocking mechanism to aid in prevention of bone screw back-out. The bone screws are provided with fixed angles available in self- tapping design. The fixed bone screws are inserted at a defined angle. The bone screws are offered in 3.5mm, 4.0mm and 4.5 mm of diameters in lengths of 12 mm - 20 mm. All components made of Ti alloy are subjected to anodizing. The implants (bone screws and cervical plates) are provided as single-use, non-sterile devices manufactured from implantable grade titanium alloy (Ti6Al4V).
The MSFX Cervical Anterior Plate System is supplied non-sterilized by end-user by moistheat, is for single use and is fabricated from titanium alloy (Ti6Al4V-ELD) that conforms to ASTM F136. Various sizes of these components are available to be used by a professional in a healthcare facility/ hospital.
The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "MSFX Mikron Cervical Anterior Plate System." This document primarily focuses on establishing substantial equivalence to a predicate device, rather than presenting a performance study with detailed acceptance criteria and results as typically seen for AI/ML-based devices.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set data, and ground truth establishment is not available in this document.
This document describes a spinal implant, which is a physical device, and not an AI/ML-based diagnostic or assistive technology. The "Non-Clinical Testing" section mentions fatigue, static compression, and static torsion tests, but these are mechanical performance tests for the physical device, not related to the accuracy or diagnostic performance of a software or AI component. The document explicitly states that "no new mechanical testing is needed on the subject device" as it is a rebranding of a predicate device.
In summary, the provided text does not contain the information required to answer the questions about acceptance criteria and study details for an AI/ML device.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.